药品名称ACEPHEN
申请号018060产品号001
活性成分ACETAMINOPHEN市场状态非处方药
剂型或给药途径SUPPOSITORY;RECTAL规格120MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构G AND W LABORATORIES INC
化学类型New formulation or new manufacturer审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
018060066APLetter2014/03/27下载
018060066APLabel2014/04/16下载
018060065APLetter2011/11/03下载
018060063APLetter2010/05/03下载
018060055APReview2003/09/11下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
018060067AP2014/12/02Manufacturing Change or Addition
018060066AP2014/03/25Labeling Revision
018060065AP2011/11/01Labeling Revision
018060064AP2010/04/01Labeling Revision
018060063AP2010/04/28Labeling Revision
018060059AP2002/02/15Manufacturing Change or Addition
018060058AP1999/03/24Control Supplement
018060056AP1996/07/29Manufacturing Change or Addition
018060055AP1997/03/31Labeling Revision
018060053AP1987/08/26Labeling Revision
018060052AP1987/10/20Labeling Revision
018060051AP1985/01/22Control Supplement
018060050AP1986/12/17Formulation Revision
018060049AP1983/05/11Expiration Date Change
018060048AP1981/04/22Distributor
018060046AP1980/12/18Manufacturing Change or Addition
018060045AP1980/11/21Control Supplement
018060044AP1980/11/25Formulation Revision
018060043AP1980/11/19Distributor
018060042AP1980/08/12Labeling Revision
018060039AP1980/02/21Labeling Revision
018060038AP1980/02/13Labeling Revision
018060037AP1980/02/13Labeling Revision
018060036AP1980/02/13Labeling Revision
018060034AP1980/02/20Manufacturing Change or Addition
018060033AP1979/09/11Labeling Revision
018060032AP1979/11/06Package Change
018060031AP1979/11/05Labeling Revision
018060030AP1979/11/05Package Change
018060029AP1979/10/22Labeling Revision
018060027AP1979/09/12Package Change
018060025AP1979/11/06Manufacturing Change or Addition
018060024AP1979/10/24Package Change
018060023AP1979/09/27Package Change
018060022AP1979/09/14Package Change
018060021AP1979/04/13Distributor
018060020AP1980/03/06Package Change
018060019AP1979/09/17Manufacturing Change or Addition
018060018AP1979/03/15Manufacturing Change or Addition
018060017AP1978/10/05Distributor
018060016AP1978/08/31Distributor
018060015AP1978/10/06Distributor
018060014AP1978/10/06Distributor
018060013AP1978/10/06Distributor
018060012AP1978/10/06Distributor
018060011AP1978/10/05Distributor
018060010AP1978/10/05Distributor
018060009AP1978/10/05Distributor
018060008AP1978/10/05Distributor
018060007AP1978/10/06Distributor
018060006AP1978/10/05Distributor
018060005AP1978/10/06Distributor
018060004AP1978/10/05Distributor
018060003AP1978/10/06Distributor
018060002AP1978/10/06Distributor
018060001AP1978/05/03Labeling Revision
018060000AP1978/02/09Approval